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Clinical Trials in China / NCT06869291
Enrolling by invitation Not applicable

Observation of the Effect and Mechanism of Multi Tunnel Minimally Invasive Treatment for Xanthelasma Palpebrarum

NCT06869291 · tracked via the Priya Life Science China tracker
Sponsor
Fuzhou First General Hospital Skin Disease Prevention and Control Hospital
Phase
Not applicable
Started
2025-02-01
Last updated
2025-03-11

Condition(s) studied

Xanthelasma Palpebrarum

Investigational drug(s) / intervention(s)

Multi level and multi tunnel puncture treatmentHeparin Sodium InjectionMulti Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection

Multi level and multi tunnel puncture treatment: Multi level and multi tunnel puncture treatment steps 1. Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; 2. Use a 1ml syringe to extract lidocaine for local anesthesia of the eyelid xanthoma lesion area; 3. Use a 1ml syringe to puncture the area between the epidermis and dermis layers, nipple layer, and reticular layer of the lesion, with the puncture endpoint at the edge of the lesion. Be careful not to penetrate the skin as much as possible, and when withdrawing the syringe, do not let the needle completely leave the puncture hole, leaving only one pinhole as much as possible; Within the same level, the distance between adjacent puncture tunnel ends is 1mm; Arrange the puncture tunnels staggered within adjacent levels; 4. Cover the injection site with gauze and maintain for 6-8 hours.

Heparin Sodium Injection: (1) Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; (2) Prepare heparin sodium and lidocaine in ratios of 1:1, and prepare 0.1ml of liquid per 1cm2 of lesion area; (3) Use a 1ml syringe to insert the needle from the edge of the lesion near the eyebrow, so that it will not cover the field of view with gauze after injection; (4) The injection depth is the gap between the epidermal layer and the dermis layer, forming an "orange peel appearance" after injection, and completely covering the lesion area; (5) Cover the injection site with gauze and maintain for 6-8 hours.

Multi Level and Multi Tunnel Puncture Treatment + Heparin Sodium Injection: (1) Disinfect the area within 1cm outside the edge of the eyelid xanthoma and lesion using iodine and cotton swabs three times; (2) Prepare heparin sodium and lidocaine in ratios of 1:1, and prepare 0.1ml of liquid per 1cm2 of lesion area; (3) Use a 1ml syringe to extract lidocaine for local anesthesia of the eyelid xanthoma lesion area; (4) Use a 1ml syringe to puncture the area between the epidermis and dermis layers, nipple layer, and reticular layer of the lesion, with the puncture endpoint at the edge of the lesion. Be careful not to penetrate the skin as much as possible, and when withdrawing the syringe, do not let the needle completely leave the puncture hole, leaving only one pinhole as much as possible; Within the same level, the distance between adjacent puncture tunnel ends is 1mm; Arrange the puncture tunnels staggered within adjacent levels; (5) Cover the injection site with gauze and maintain for 6-8 hours.

Study summary

Dear research participants:

Participants will be invited to participate in a research project led by the Dermatology Prevention and Treatment Institute of Fuzhou First General Hospital (Huang Zhiyong) (15260471946). The research project is titled "New Directions in the Treatment of Xanthelasma Palpebrarum: Research on Hematoma Related Treatment Methods and Mechanisms".

Participants' participation in this study is voluntary, and this informed consent form provides participants with some information to help participants decide whether to participate in this clinical study. This study has been reviewed and approved by the Ethics Committee of the Dermatology Prevention and Treatment Hospital of Fuzhou First General Hospital. The Ethics Committee office phone number is 0591-83787173. If participants agree to join this study, please read it carefully and if participants have any questions, please raise them with the researcher responsible for the study.

Research objective:

Exploring whether multi tunnel minimally invasive treatment and heparin induced hematoma can initiate immune response through DAMP, mediate Toll like receptor activation of Th2 cells, secrete IL-4 and IL-13 to activate neutrophils and M2 macrophages, and then engulf cholesterol, triglycerides, and apolipoprotein in xanthelasma palpebrarum, ultimately leading to its disappearance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Clinical diagnosis of xanthelasma palpebrarum * Must be able to receive heparin sodium injection and multi tunnel minimally invasive treatment Exclusion Criteria: * Hemophilia * Coronary heart disease * Myocardial infarction * Cerebral infarction

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
No. 243 Xihong Road, Gulou District, Fuzhou City, Fujian Province Fuzhou Fujian
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06869291 on ClinicalTrials.gov ↗ ← All trials in China